Method and apparatus for establishing context among events and optimizing implanted medical device performance

ABSTRACT

An apparatus and method for adjusting the performance of an implanted device based on data including contextual information. Contextual information, including operational and performance data concerning the implanted device as well as the patient with the implanted device, is stored by a portable electronic device. In one embodiment, the portable electronic device is adapted for battery operation and includes a personal digital assistant (PDA). The portable electronic device is adapted for use as an interface to conduct wireless communications with the implanted device. In one embodiment, the portable electronic device interfaces with a clinical programmer for use by a physician.

RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.12/891,338, filed on Sep. 27, 2010, now issued as U.S. Pat. No.8,160,716, which is a Continuation of U.S. application Ser. No.11/381,051, filed on May 1, 2006, now issued as U.S. Pat. No. 7,805,199,which is a Continuation of U.S. application Ser. No. 10/093,353 filed onMar. 6, 2002, now issued as U.S. Pat. No. 7,043,305, which areincorporated herein by reference.

TECHNICAL FIELD

The present subject matter relates to implantable devices and morespecifically, to a method and system for optimizing performance of animplanted medical device based on contextual information derived fromthe implanted medical device, external sensors, user provided data, orother sources.

BACKGROUND

A normal, healthy, heart beats at a regular rate. Irregular heart beats,known as cardiac arrhythmia, on the other hand, may characterize anunhealthy condition. Another unhealthy condition is known as congestiveheart failure (ACHF@). CHF, also known as heart failure, is a conditionwhere the heart has inadequate capacity to pump sufficient blood to meetmetabolic demand. CHF may be caused by a variety of sources, including,coronary artery disease, myocardial infarction, high blood pressure,heart valve disease, cardiomyopathy, congenital heart disease,endocarditis, myocarditis, and others.

Unhealthy heart conditions may be treated using a cardiac rhythmmanagement (CRM) system. Examples of CRM systems, or pulse generatorsystems, include defibrillators (including implantable cardioverterdefibrillator), pacemakers and other cardiac resynchronization devices.

Typically, a pulse generator is surgically implanted under the skin, butoutside the thorax of a patient and includes one or more conductive leadwires that deliver an electrical pulse to the heart according to atherapy schedule. The electrical pulses may be delivered on apredetermined schedule, on an as needed basis, or according to otherpredetermined criteria.

In some cases, the operation of the pulse generator may be adjustedusing an external programmer. The programmer allows a physician totailor the performance of the pulse generator without performing surgeryon the patient. The programmer may communicate with the pulse generatorby wireless technology such as radio frequency communication.

A typical programmer includes a wand coupled to a desktop unit by aflexible electrical cord. In use, the operator positions the wand nearthe implanted device and a signal from the programmer is wirelesslytransmitted to the device. Data is extracted from the transmitted signaland stored in internal memory within the implanted device. The implanteddevice then delivers therapy according to the memory contents. Thememory contents may include operating parameters or programming. Forexample, the implanted device may be wirelessly programmed to deliverelectrical shocks at a greater amplitude or with greater frequency.

The ability to wirelessly program an implantable device has taxed theperformance and capacity of device data storage and the device powersupply and also compelled the addition of a transceiver suitable forcommunicating with the programmer. To address these needs, somemanufacturers have adapted their devices to include additional circuitryas well as increased battery capacity. To the chagrin of the patient,such improvements have, in some instances, resulted in larger case sizesfor the implantable device.

Consumer, and therefore, manufacturers, of implanted medical deviceshave demonstrated a clear desire for, among other things, reduced devicesize, increased functionality, and increased reliability and longevity.Efforts to provide increased functionality and increased reliabilityhave tended to frustrate the objective of reduced device size. Thus,there is a need for an implanted device with reduced size and yetpermits field programmability along with increased reliability.

At initial implantation, the medical device is programmed to providetherapy based on known parameters and conditions of the patient.Follow-up programming of the implanted device, which may take place at adoctor's office, may be based on stored data and patient input. However,for many patients, follow-up visits are infrequent and thus, patientsare unable to provide their physician with accurate or completeinformation regarding the events surrounding a particular cardiac event.For example, few patients are able to provide reliable data concerningtheir dietary intake just prior to a period of increased heart rate thatmay have occurred three weeks ago. Thus, there is a need for collectingtimely patient data with improved accuracy.

SUMMARY

The present subject matter includes, among other things, a system andmethod for collecting timely data from a variety of sources andcorrelating the data with data provided by an implanted medical device.In one embodiment, patient responses are collected using a portabledevice. The portable device may present questions or data entry promptsor otherwise solicit a response from the patient. The prompts mayconcern subjective or objective data. In one embodiment, the questionsinclude “Have you felt dizzy in the last two hours?,” “Are youbreathless?,” “Do you feel palpitations?,” “Do you have any chest pain?”and “How many alcoholic drinks have you consumed in the previous 2hours?” In one embodiment, data from a sensor coupled to the implantedmedical device is communicated to the portable device. The data includesphysiological information concerning the performance of the implantedmedical device or measured parameters concerning a particular body organor system. In one embodiment, data from a sensor not coupled to theimplanted medical device is communicated to the portable device.

By way of example, in one embodiment, the patient is implanted with amedical device as part of a cardiac rhythm management (CRM) system. TheCRM system includes a pacemaker defibrillator with an accelerometer andheart rhythm sensor. In addition, the patient is also fitted with animplanted respiration monitor with in the CRM system. In this example,the portable device, which is carried external from the body of thepatient, prompts the patient with questions concerning such topics astheir sleep patterns, dietary and drug intake, visible edema and otherrelevant signs and symptoms. The portable device also receives data fromthe defibrillator with the accelerometer, heart rhythm monitor and therespiration monitor.

At a clinical setting, or by a remote communication coupling, thepatient's doctor can access the portable device and retrieve the storeddata from the various inputs. The retrieved data can be analyzed fortrends as part of a wellness monitoring system and therefore, enableimproved medical care and reduce healthcare utilization.

In one embodiment, the portable device is coupled to, or incorporatedwithin a personal digital assistant (PDA). Thus, the PDA communicateswirelessly with an implanted medical device as well as communicates witha programmer. In addition, the portable device is adapted to executeinstructions that prompts the user for information and stores theresponses. In one embodiment, the user entered data is received inresponse to a prompt or message. In one embodiment, the user is able toenter data in a free-text entry mode without regard to a particularschedule. In one embodiment, the portable device also receives data fromnon-invasive sensors or detectors. Examples of non-invasive sensorsinclude an arterial blood pressure monitor, a respiration monitor, ablood sugar detector, a body mass scale as well as other devices. Theportable device communicates with the non-invasive sensors or detectorsin a wireless manner or via a wired coupling.

In one embodiment, the portable device may receive data from animplanted device other than that which is controllable by way of theprogrammer. For example, a patient may be equipped with an implantedcardiac pacing device as well as a separate implanted sensor formonitoring a body parameter or organ and the portable device receivesdata from both implanted devices and yet the programmer interfaces withand controls the operation of the cardiac pacing device and not theseparate implanted sensor.

In various embodiments, the portable device is coupled to a PDA,(variously referred to as a personal digital, or data, assistant), aportable telephone (including a cellular telephone or a cordlesstelephone), a pager (one way or two way), a handheld, palm-top, laptop,portable or notebook computer, or other such battery operated portablecommunication device, all of which are herein referred to as portablecommunicators.

In one embodiment, the portable device operates independently andwithout coupling to a portable communicator. It will be appreciated thateither the portable device or the portable communicator may provide thedata storage capacity, processing, display, or user input means asdescribed herein.

In one embodiment, the portable device includes circuitry or executableprogramming and communicates wirelessly with the implanted medicaldevice. In one embodiment, the portable device is coupled by a wiredlink to a remote programmer or other network communication device. Inone embodiment, the device includes a separate module that communicateswirelessly with the implantable medical device and the separate moduleis user-removable from the portable device.

The present subject matter also includes a method and apparatus to allowa portable communicator, such as a PDA or cellular telephone, tointerface between an implantable medical device and a programmer. Theprogrammer may be coupled to the portable device by a networkcommunication connection. For example, in one embodiment, a remoteprogrammer can access a cellular telephone coupled to a portable devicevia the Internet, a private area branch exchange (PABX, also known as aPBX), an intranet network, an ethernet connection or other remotecommunication means. In one embodiment, the portable device is coupledto a portable telephone with which the programmer communicates using apublic switched telephone network (PSTN) and the portable telephone isin wireless communication with the implantable medical device.

The present system may allow increased data logging, thereby permittinganalysis otherwise not possible using the limited data storage capacityand battery capacity of an implanted device.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A illustrates a patient with an implanted medical device holding aportable communicator as well as a screen shot of the portablecommunicator.

FIGS. 1B, 1C, 1D, 1E illustrate screen shots appearing on a portablecommunicator according to one embodiment.

FIG. 1F illustrates a block diagram of an embodiment of the presentsystem having a implantable medical device, a portable device, and aprogrammer.

FIG. 2 illustrates a block diagram illustrating communication channelsbetween involuntary data sources, a portable device, a programmer, anetwork, and a user data source.

FIG. 3 illustrates a perspective view of a PDA with a removable portabledevice, in communication with an implantable cardiac device coupled to aheart.

FIG. 4 illustrates a system according to the present subject matterincluding a PDA wirelessly coupled to an implantable cardiac device andwirelessly coupled to the Internet and further coupled to a remoteprogrammer.

FIG. 5 illustrates a system according to the present subject matterincluding a PDA wirelessly coupled to an implantable cardiac device andcoupled to a programmer via a wired connection.

FIG. 6A illustrates a block diagram of an implantable medical device forone embodiment of the present system.

FIG. 6B illustrates a block diagram of a portable device for oneembodiment of the present system.

FIG. 7 illustrates one embodiment of the present subject matter havingan implantable medical device communicating data to a portable devicewhich, in turn, communicates with a programmer and the programmer iscoupled to the implantable medical device.

FIG. 8 illustrates one embodiment of the present system including animplantable medical device receiving data from a non-invasive datasource provided to a portable device, and further communicating with aprogrammer.

FIG. 9 illustrates one embodiment of the present system including a datasource that provides data to a portable communicator which is coupled toa programmer which communicates with an implantable medical device.

FIG. 10 illustrates, in block diagram, communication paths between animplantable medical device and a portable device.

FIG. 11 illustrates selected types of user input data.

FIG. 12 illustrates selected types of external devices.

FIG. 13 illustrates selected types of implantable devices.

FIG. 14 illustrates an algorithm executed by one embodiment of thepresent subject matter.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the spirit and scope of thepresent invention. The following detailed description is, therefore, notto be taken in a limiting sense, and the scope of the present inventionis defined by the appended claims and their equivalents. In thedrawings, like numerals describe substantially similar componentsthroughout the several views. Like numerals having different lettersuffixes represent different instances of substantially similarcomponents. As used herein, the term data includes both data andprogramming.

In accordance with the present system, FIG. 1A illustrates patient 455implanted with implantable medical device 25 coupled to heart 15A byleads 20A and 20B. In one embodiment, the combination of leads 20A and20B and device 25 provides cardiac rhythm management pulsing and alsosenses one or more physiological parameters of heart 15A. Implantablemedical device 25 communicates wirelessly with portable device 35 shownin the left hand of patient 455. Portable device 35 is external to thebody of patient 455 and, in the embodiment shown, is coupled to portablecommunicator 80. In one embodiment, portable communicator 80 includes aPDA.

In one embodiment, implantable medical device 25 provides data includingheart rhythm, breathing, activity, and contractility, as illustrated at450. Other types of data derived from implantable systems are alsocontemplated, as noted at 450. For example, in one embodiment, arespiration sensor is implanted into patient 455 and communicates withportable device 35. Data received from such implantable systems may beperceived as involuntary, or passive, data since the patient has nocontrol over the process of collecting and transmitting the data fromsuch sources.

In one embodiment, portable communicator 80 includes a touch-sensitivedisplay screen for displaying information to a user or patient 455.Depending on the application executing on portable communicator 80, thedisplay screen may provide prompts, messages, questions, or other datadesigned to elicit an input from patient 455. For example, in oneembodiment, portable communicator 80 may display a screen shot as shownat 400. Screen shot 400, entitled “Non-invasive Data Entry Screen”provides links to questions or prompts as shown in the figure. Datareceived from such interactive prompts may be perceived as voluntary, oractive, data since the cooperation and active input of the patient ispart of the data collection process. The user voluntarily providesanswers in response to prompts that appear on the screen. At each of 405through 445, the patient may be linked to one or more questionsconcerning the general topic appearing in screen shot 400. For example,at 405, the link “Blood Pressure” may lead to one or more questionsconcerning the patient's blood pressure. At 410, the patient may beprompted for information concerning their body weight. At 415 thepatient may be prompted to supply data concerning their sleep patterns(bedtime, sleep time, perceived arousals, perceived sleep quality) orrecent life experiences. At 420, the patient may be prompted for dataconcerning their perceived quality of life (Q of L). At 425, the patientmay be prompted to supply information concerning their perceivedphysical strength. At 430, the patient may be prompted to supplyinformation regarding their mental acuity. In one embodiment, thepatient may be presented with a series of short questions and based onthe responses received, portable communicator 80 calculates a parametercorresponding to mental acuity. At 435, the patient is prompted for dataconcerning their dietary intake. At 440, the patient is prompted fordata concerning their voiding patterns. At 445, the patient is promptedto supply information concerning drug therapy compliance.

Wellness monitoring system 460 is in communication with portablecommunicator 80, and thus, portable device 35. Wellness monitoringsystem 460 provides analysis of voluntary and involuntary data gatheredby portable device 35. In one embodiment, wellness monitoring system 460includes computer and programming that conducts data analysis andidentifies trends that may improve patient health and medical care.

FIG. 1B illustrates a screen shot of questions that may be posed in oneembodiment. Questions and prompts appearing on a display coupled toportable device 35 may concern objective or subjective matter. Questionsand prompts illustrated in the figure, concern the topics of exercising,prescribed medications, non-prescription drug intake, alcoholconsumption and recent sleep patterns, however it will be appreciatedthat those shown are exemplary only and that other questions or promptsmay also be used. In one embodiment, prompts are used in lieu ofquestions. For example, a prompt concerning exercising may be presentedas “Enter the number of minutes and intensity of walking on a treadmill”thus calling for the user to enter numbers and/or levels of intensity onan analog scale.

FIG. 1C illustrates a screen shot of questions concerning alertness,unusual sensations, chest pain, anxiety, and stress. As noted otherquestions or subject matter may be presented to the patient.

FIG. 1D illustrates a screen shot of questions directed to eating abalanced diet, lethargy, insomnia, voiding patterns, and drug anddietary supplement intake.

FIG. 1E illustrates a screen shot of questions directed to exerciseplans, recent alcohol consumption, weight relative to a target bodyweight, signs of edema and breathing difficulty (such as unexpectedshortness of breath).

FIG. 1F illustrates, in block diagram form, an embodiment of the presentsystem. In the figure, system 10 is shown to include an implantablemedical device, here marked IMD 25, which is shown coupled, by lead 20,to heart 15. In one embodiment, IMD 25 includes an implantable cardiacdevice (ICD), CRM device, pulse generator, or other implanted medicaldevice that provides therapy to a patient or an organ of a patient, orthat provides data derived from measurements internal to a patient. Inthe figure, IMD 25 is further shown coupled to portable device 35 bylink 30. In one embodiment, portable device 35 includes a portablecommunicator. Portable device 35 is further coupled to programmer 45 bylink 40.

In one embodiment, lead 20 includes a catheter or other implanted leadhaving one or more electrodes for the delivery of electrical energy toselected portions of an organ, or tissue, of a patient or for receivingelectrical signals indicative of the health of the patient or a selectedorgan. In one embodiment, lead 20 is coupled to a human or animal heart,however, other organs may also be monitored or treated. In oneembodiment, the housing of IMD 25 is electrically conductive and servesas an electrical conductor and operates in conjunction with a signal ona conductor portion of lead 20.

In one embodiment, IMD 25 includes a pacing device (commonly referred toas a pacemaker) a defibrillator, heart failure therapy device, cardiacresynchronization device or other medical device. In one embodiment, IMD25 also includes circuitry and programming adapted to monitor thecondition and performance of the pulse generator or other implanteddevice. For example, in one embodiment, IMD 25 provides data concerningthe remaining battery condition for a power supply coupled to IMD 25.Such data may include information regarding remaining battery capacityor life, battery internal resistance or other measurable parameter. Inother embodiments the data includes information regarding the electricaltherapy provided by IMD 25. For example, in one embodiment, such dataincludes the peak voltage level, the rate, or frequency, of therapy, theprofile of the delivered shock or other parameters. In variousembodiments, IMD 25 is controlled by digital or analog signals and inone embodiment, IMD 25 generates data in digital or analog form.

In one embodiment, IMD 25 includes a program executing on an internalprocessor that controls the operation of the device. The programinstructions reside in a memory accessible to the internal processor. Bychanging the program, or memory contents, the present system allows theoperating program of IMD 25 to be dynamically tailored to a particularpatient or condition. In one embodiment, the operating system, or memorycontents of IMD 25 can be changed using wireless communication.

In one embodiment, IMD 25 includes a wireless transceiver. Thetransceiver operates using radio frequency transmissions,electromagnetic transmissions, magnetic coupling, inductive coupling,optical coupling, or other means of communicating without need of a wireconnection between IMD 25 and another transceiver. In one embodiment,IMD 25 is coupled to a wireless transceiver by a wired connection.

In one embodiment, IMD 25 performs a data acquisition function. Forexample, a detector coupled to IMD 25 is adapted to monitor a fluidpressure, such as blood or urine. In one embodiment, the detector isadapted to monitor respiration, stress level, or other measurablebiometric parameter. In one embodiment, monitoring includes determiningan absolute or relative value for a particular biometric parameter.Internal memory within IMD 25 may be adapted to store a comparison valuewhich may then be compared with a measured value thereby determining theperformance of IMD 25 or the health of the patient.

Link 30 is a wireless communication link between IMD 25 and portabledevice 35. Link 30 allows communication in one or two directions. Forexample, in one embodiment, data from IMD 25 is communicated to portabledevice 35 with no data transmitted from portable device 35 to IMD 25. Inthis manner, portable device 35 functions as a data storage facility forIMD 25. In one embodiment, data stored in portable device 35 can beaccessed by a treating physician and used for diagnosis, therapy orother purposes. Programming and controlling the operation of IMD 25 isperformed using a programmer adapted to transmit commands, data or codeto IMD 25. In one embodiment, portable device 35, or portablecommunicator 80, executes programming to analyze and process the datareceived from IMD 25. In one embodiment, communication link 30 maypreclude transfer of data from portable device 35 to IMD 25 or topreclude transfer of data from IMD 25 to portable device 35. Forexample, in one embodiment, portable device 35 executes programmingwhich automatically adjusts the performance or operation of IMD 25independent of programmer 45 and under certain predetermined conditions,it may be desirable to preclude such automatic adjustments.

In one embodiment, data is communicated from portable device 35 to IMD25 with no data transmitted from IMD 25 to portable device 35. In thismanner, portable device 35 functions as an interface to communicatecommands, data or code to IMD 25.

In one embodiment, data is communicated bidirectionally between IMD 25and portable device 35. In various embodiments, link 30 entails a singlebidirectional communication channel or includes multiple unidirectionalcommunication channels which, when viewed as a whole, providebidirectional communication. In one embodiment, a unidirectionalcommunication channel operates using a particular frequency orcommunication protocol. For example, link 30 include a wireless radiofrequency link compatible with a transmitter and receiver that usesfrequency hopping, spread spectrum technology.

In one embodiment, internal memory within IMD 25 provides storage fordata related to the CRM therapy provided to heart 15. The data mayrelate to the electrical, chemical or mechanical operation of the heart.In addition, IMD 25 includes memory for programming, comparison andother functions. In one embodiment, the contents of the memory regulatesthe operation of IMD 25.

In one embodiment, portable device 35 is coupled to a battery operatedportable communicator having a processor, memory, and an outputinterface to communicate with a user and an input interface to receiveuser entered data. One suitable example of a portable communicator isthat of a PDA. Commercial suppliers of PDAs include Palm, Inc. (SantaClara, Calif.), Microsoft Corporation (Redmond, Wash.) and HandspringInc., (Mountain View, Calif.) and others. Such devices typically includea display screen for presenting visual information to a user and awriting surface for entry of data using a stylus. Data may also beentered using a keyboard coupled to the portable communicator or bymeans of a wired or wireless communication link. Some portablecommunicator models also include an audio transducer, or soundgenerator, adapted to produce sounds that are audible by a user. In oneembodiment, data from IMD 25 or programmer 45 is displayed on a screencoupled to portable device 35.

In one embodiment, portable device 35 is coupled to a portable telephone(such as a cellular telephone or a cordless telephone), a pager (one wayor two way), or a computer (such as a handheld, palm-top, laptop, ornotebook computer) or other such battery operated, processor based,portable communication device.

In one embodiment, portable device 35, or portable communicator 80,includes data storage and includes programming and instructions toconduct data processing. In one embodiment, the data storage capacity ofportable device 35 or portable communicator 80 augments the data storagecapacity of IMD 25, thus enabling a clinician to access a greater amountof contextual information regarding the medical condition of a user. Forexample, but not by way of limitation, the contextual information mayassist in discovering and understanding relationships among differentevents.

In one embodiment, a wireless receiver is coupled to portable device 35for purposes of receiving data from IMD 25. The wireless receiver may beinternal or external to the housing of portable device 35. In oneembodiment, a wireless transmitter is coupled to portable device 35 forpurposes of transmitting data to IMD 25. The wireless transmitter may beinternal or external to the housing of portable communicator 80. In oneembodiment, a wireless transceiver is coupled to portable device 35 forpurposes of both transmitting data to, and receiving data from, IMD 25.The wireless transceiver may be internal or external to the housing ofportable device 35. In one embodiment, portable device 35 includes atelemetry head that is positioned near IMD 25 to facilitate wirelesscommunications.

In one embodiment, circuitry or programming allows portable device 35 totrigger an alarm under predetermined conditions. For example, portabledevice 35 may sound an audible alarm or transmit an alarm signal if abiometric parameter exceeds a particular value or is outside a specifiedrange of values. The alarm signal can be received by programmer 45 or adesignated physician.

Referring again to FIG. 1F, link 40 is shown to couple portable device35 with programmer 45. In one embodiment, link 40 includes a wired orwireless link that allows data communication between portable device 35and programmer 45. In one embodiment, data is exchanged between portabledevice 35 and programmer 45 by means of a removable storage media.

In one embodiment, programmer 45 includes a processor based apparatusexecuting programming to communicate with IMD 25, portable device 35, orboth. Typically, a clinician or physician will operate programmer 45 tocommunicate with IMD 25 using portable device 35 as a data interface. Inparticular, one embodiment provides that data from IMD 25 can beretrieved by accessing the memory of portable device 35. In oneembodiment, programmer 45 transmits data to IMD 25 via portable device35.

FIG. 2 illustrates, in block diagram form, an embodiment of presentsystem 10A. In the figure, IMD 25A is coupled to programmer 45A bywireless link 30B and to portable device 35A by wireless link 30A.Programmer 45A is further coupled to portable device 35A by link 40A andto network 50 by link 40C. Portable device 35A is further coupled tonetwork 50 by link 40B. Portable device 35A receives data frominvoluntary data source 58 and exchanges data with user data source 65.Link 30A, link 30B, link 40A, link 40B, link 40C, and link 70 beararrowheads on each end, and thus, are illustrated as bidirectionalcommunication links. Nevertheless, it will be appreciated that some orall of the bidirectional communication links may be unidirectional.Furthermore, it will be appreciated that not all of the elementsappearing in FIG. 2 may be present in one embodiment of system 10A.

To the extent that IMD 25A, portable device 35A, programmer 45A, link30A, and link 40A are described elsewhere in this document, thefollowing discussion concerns the elements not earlier described.

IMD 25A is coupled to programmer 45A via wireless link 30B. In oneembodiment, link 30B include a handheld wand that is placed in thevicinity of IMD 25A to allow communication of data. In the figure, link30B is shown to include a bidirectional communication channel.

Portable device 35A is coupled to programmer 45A via network 50 by wayof link 40B and link 40C. It will be appreciated that network 50 mayinclude the Internet, a private intranet, a wide area network (WAN), alocal area network (LAN), or other communication network. In oneembodiment, programmer 45A accesses network 50 using an ethernetconnection, a dial-up connection, a cable modem connection, a digitalsubscriber line (DSL) connection, or other wired or wireless networkconnection. In one embodiment, portable device 35A accesses network 50using an ethernet connection, a dial-up connection, a cable modemconnection, a digital subscriber line (DSL) connection, or other wiredor wireless network connection.

Portable device 35A is coupled to a block modeled in the figure asinvoluntary data source 58. Involuntary data source 58, in oneembodiment, includes IMD 25A and ex-IMD data source 55, either of whichcan provide data to enable system 10A to tailor therapy of IMD 25 in anefficient manner. As described above, IMD 25A may include sensors thatprovide information, ultimately, to programmer 45A. In addition, in oneembodiment, ex-IMD data source 55 may include an externally worn sensoror an implanted device. In one embodiment, an implanted device includesa second implanted medical device adapted to monitor a body organ orfunction, such as a blood oxygen monitor. Also by way of example, oneexternally worn sensor includes a non-invasive data source such as atemperature monitor, blood pressure monitor or respiration monitor. Inone embodiment, ex-IMD data source 55 is non-user worn. For example, inone embodiment, data is provided by an ambient temperature monitor oratmospheric pressure monitor. In one embodiment, a plurality of ex-IMDdata sources 55 are provided. Data sources other than those enumeratedherein are also contemplated.

Data provided by ex-IMD data source 55 is coupled to portable device 35Aby link 60. In one embodiment, link 60 includes a wired coupling and inanother embodiment, a wireless coupling. In one embodiment, ex-IMD datasource 55 is coupled to, and integrated with, portable device 35A.

The data provided by ex-IMD data source 55 is received by portabledevice 35A. In various embodiments, processing of the data is conductedby portable device 35A or programmer 45A. In one embodiment, the data isprovided in real time, (either continuously or according to apredetermined schedule) or upon a change exceeding a predeterminedamount, or upon request or inquiry from programmer 45A or portabledevice 35A.

Portable device 35A is coupled to a block modeled in the figure as userdata source 65, by link 70. In one embodiment, user data source 65provides data volunteered by the user and is integrated with portabledevice 35A. User data source 65 includes, in one embodiment, a displayscreen, an audio generator and an input device. In operation, portabledevice 35A displays a question or prompt directed to the user and theuser is instructed to respond by providing a manual input. For example,in one embodiment, portable device 35A sounds a characteristic tone anddisplay a question concerning the well-being of a user. The user, inresponse to the prompt, may use a stylus, keyboard, voice response, orother means to indicate a suitable answer to the question presented. Thedata received from the user prompt is then stored by portable device35A. In one embodiment, processing of the data received from user datasource 65 is done by portable device 35A or by programmer 45A. User datasource 65 may generate a prompt according to a predetermined schedule,randomly, or based on data received from portable device 35A, IMD 25 orenvironmental data source 55. In one embodiment, data is entered by theuser on the user's initiative.

In one embodiment, programmer 45A receives data from several datasources and communicated via any of several data communication channels.For example, programmer 45A may receive data from IMD 25A via link 30Bor via portable device 35A by way of link 30A and link 40A. In addition,programmer 45A may receive data from IMD 25A via network 50 by way oflink 30A, link 40B and link 40C. Data may be acquired using an interruptdriven system or on a query-based system.

In addition, one embodiment provides that data from IMD 25A iscommunicated to programmer 45A via any of several communication paths.For example, data may be communicated to programmer 45A using link 40A,40B, 40C, 60 or 70.

FIG. 3 illustrates a perspective view of an embodiment of the presentsubject matter. In the figure, portable communicator 80 includes adisplay screen 80B, a plurality of user operable buttons 80D, andexpansion port 80A. Expansion port 80A receives, and electricallycouples to, portable device 35B. Stylus 80C may be used to manuallyenter data using screen 80B. Portable device 35B is wirelessly coupledto implanted device 25 which, in the embodiment shown, is furthercoupled by electrode 20 to heart 15.

Consider the operation of the embodiment in FIG. 3. Link 30 isillustrated as a bidirectional link and thus, data from device 25 iswirelessly telemetered to portable device 35B. In addition, data, orprogramming from portable device 35B is wirelessly telemetered to device25. At various times, portable communicator 80 will generate a promptcalling for a response in the form of a user input. A user may enterdata using any of a variety of means. For example, a response may beentered using stylus 80C, buttons 80D, or an external keyboard. In oneembodiment, portable communicator 80 responds to voice commands receivedfrom a user. A prompt may be visually displayed using screen 80B oraudibly generated using an internal sound generator. Manually entereddata received from a user, as well as data received from other inputs(some of which were described relative to FIG. 2) is stored usingportable communicator 80. The data stored in portable communicator 80 isthen available for processing, and to tailor the therapy. Data may beprocessed by portable communicator 80, portable device 35, or byprogrammer 45.

In addition to data entry, in one embodiment, stylus 80C, along withscreen 80B, and buttons 80D, allow a user to exercise limited controlover the operation of implantable medical device 25. In one embodiment,reasonable constraints on the authority to change the operation ofdevice 25 are established and implemented by a clinician usingprogrammer 45.

FIG. 4 illustrates a perspective view of an embodiment of the presentsubject matter. In the figure, portable communicator 80 includeswireless communication antenna 80E. Portable communicator 80, in thisembodiment, is adapted for wireless Internet access to network 50A usinglink 40B. In one embodiment, link 40B includes a radio frequencycommunication link. In this embodiment, portable communicator 80includes an internally mounted portable device 35.

Programmer 45 accesses Internet 50A via link 40C. In one embodiment,link 40C includes a dial-up modem connection, a cable modem connection,a DSL connection, an ISDN line, or other channel providing access to theInternet.

Using the system of FIG. 4, a user may compile contextual informationregarding ICD 25, as well as himself, using portable communicator 80. Inone embodiment, a clinician using programmer 45 may remotely access thedata stored in portable communicator 80 using link 40C, Internet 50A andlink 40B. In this manner, programmer 45 may wirelessly receive the data,process the data, and transmit data and code to change the futureoperation of device 25.

FIG. 5 illustrates a perspective view of an embodiment of the presentsubject matter. In the figure, portable communicator 80 includesportable device 35 and is coupled to IMD 25, heart 15 and electrode 20,by wireless link 30. Portable communicator 80 is further coupled toprogrammer 45 by link 40A and connector 40D.

Using the system of FIG. 5, a clinician operating programmer 45 is ableto exchange data or code with portable communicator 80 using link 40A.Connector 40D is a multi-conductor connector providing access to data ofportable communicator 80. Portable device 35 is internal to portablecommunicator 80. It will be appreciated that link 40A may coupleportable communicator 80 to a local area network or other communicationnetwork. For example, portable communicator 80 may be connected to aPSTN using link 40A, and thus, programmer 45 may exchange data withportable communicator 80 using a modem coupled to PSTN.

FIG. 6A illustrates a block diagram of an implanted medical device forone embodiment of the present system. In the figure, IMD 25 is shown toinclude processor 100, memory 105, update module 110 and transceiver115. In operation, processor 100 governs the operation of IMD 25 andexecutes programming stored in memory 105. In addition to the executableprogram, memory 105 also includes data storage regarding the patient andIMD 25. Update module 110 operates in conjunction with processor 100,memory 105 and transceiver 115 to receive, install, and execute newinstructions for execution by processor 100.

FIG. 6B illustrates a block diagram of a portable device for oneembodiment of the present system. In the figure portable device 35 isshown to include long term data storage 120, input/output 125,controller 130, IMD transceiver 135 and communication interface 140.Long term data storage 120 augments the data storage capacity of memory105 of IMD 25. In one embodiment, storage 120 is of a greater capacitythan that of memory 105. In addition, storage 120 may be of a physicallylarger size, be less expensive than medical grade implantable memory,and more robust.

Input/output 125, IMD transceiver 135 and communication interface 140,in conjunction with controller 130 enables receipt and transmission ofdata from IMD 25 as well as data from programmer 45. IMD transceiver 135and transceiver 115 provide a wireless telemetric link between IMD 25and portable device 35.

Portable device 35 may be coupled to a portable communicator and one ormore of long term data 120, input/output 125, controller 130, IMDtransceiver 135, or communication interface 140 may be provided by theportable communicator.

FIG. 7 illustrates in block diagram, an embodiment of the presentsubject matter. In one embodiment, CRM therapy, for CHF is provided toheart 15 by IMD 25 via lead 20. Data accessible to IMD 25 is wirelesslycommunicated to portable device 35 via link 30C. Portable device 35operates as a data storage facility for IMD 25 and in one embodiment,performs data processing.

Programmer 45 receives data from portable device 35 via link 40E. In oneembodiment, programmer 45 performs data processing. Updated programmingfor execution by IMD 25 is determined by programmer 45 and transmittedwirelessly to IMD 25 via link 30D. Updated programming may be based ondata received from portable device 35, as well as manual inputs receivedat programmer 45. IMD 25 includes a transmitter to communicate usinglink 30C and a receiver to communicate using link 30D.

In the embodiment illustrated in FIG. 7, portable device 35 provides acommunication link for data communicated from IMD 25 to programmer 45.It will be understood that other data may also be received, processedand stored by portable device 35 as well as programmer 45. For example,a non-invasive data source may provide data to portable device 35.

FIG. 8 illustrates in block diagram, an embodiment of the presentsubject matter. In the figure, CRM therapy is provided to heart 15 byIMD 25 via lead 20. In the embodiment shown, IMD 25 includes a wirelessreceiver that receives transmissions from portable device 35 via link30E. In addition, portable device 35 also receives data fromnon-invasive data source 55A via link 60A. Link 60A may include a wiredor wireless link. Data accessible to portable device 35 is communicatedto programmer 45 via link 40F. Link 40F may be a wired or wireless link.Portable device 35 operates as a data storage facility for non-invasivedata source 55A and in one embodiment, performs data processing. In oneembodiment, programmer 45 performs data processing. Updated programmingfor execution by IMD 25 is determined by programmer 45 and communicatedto portable device 35 by link 40F. Updated programming is transmittedwirelessly to IMD 25 via link 30E. Updated programming may be based ondata received from portable device 35, as well as manual inputs receivedat programmer 45. IMD 25 includes a receiver to communicate using link30E.

In the embodiment illustrated in FIG. 8, portable device 35 provides acommunication link for data communicated from programmer 45 to IMD 25.As illustrated, non-invasive data, or other environmental data, may alsobe received, processed and stored by portable device 35 as well asprogrammer 45.

FIG. 9 illustrates in block diagram, an embodiment of the presentsubject matter. In the figure, CRM therapy is provided to heart 15 byIMD 25 via lead 20. Data source 55B communicates with portable device 35via link 60B. Portable device 35 operates as a data storage facility fordata source 55B and in one embodiment, performs data processing.Programmer 45 receives data from portable device 35 via link 40E. In oneembodiment, programmer 45 performs data processing. Data and updatedprogramming for execution by IMD 25 is determined by programmer 45 andtransmitted wirelessly to IMD 25 via link 30D. Updated programming maybe based on data received from portable device 35, as well as manualinputs received at programmer 45. IMD 25 includes a wireless receiver tocommunicate using link 30D.

In the embodiment illustrated in FIG. 9, it will be understood thatother data may also be received, processed and stored by portable device35 as well as programmer 45. For example, a non-invasive data source oruser entered data may provide data to portable device 35.

FIG. 10 illustrates a portion of an embodiment of the present subjectmatter. In the figure, IMD 25 is in wireless communication with portabledevice 35. Arrow 30C illustrates the direction of data communicationfrom IMD 25 to portable device 35. In one embodiment, data from IMD 25includes, but is not limited to, operational data concerning theperformance of IMD 25, diagnostic data concerning either IMD 25 or thepatient, as well as patient medical information. Arrow 30E illustratesthe direction of data and program information from portable device 35 toIMD 25. In one embodiment, data and program information from portabledevice 35 includes, but is not limited to, updated operating code,operational parameters, instructions, and executable code.

FIG. 11 illustrates, in block diagram form, user input data implementedin one embodiment of the present system. It will be appreciated thatmore or less than the illustrated data may be implemented in anembodiment. The user input data may be received from a user based on aprompt provided to the user, on an ad hoc basis as determined by theuser, or as determined by a processor of the present system. The usermay enter data using a menu based system, a graphical user interface(GUI), textual data or numerical data. FIG. 2 illustrates an embodimentof the present system having user data source 65 providing user inputdata.

At 155, the input data includes a sleep schedule. The sleep schedule maydescribe the sleep (or wake) times of the user. The user may enter thedata into portable device 35. In an embodiment including portable device35 coupled to portable communicator 80, the data may be entered, forexample, using stylus 80C, keys 80D or a keyboard. At 160, the inputdata includes a user-selected quality of life index. The user may selectand specify a suitable response based on subjective or objectivecriteria. At 165, the input data includes an entry corresponding to theuser's physical strength. At 170, the input data includes an entrycorresponding to the mental acuity of the user. In this instance,portable communicator 80 may determine a value based on predeterminedcriteria which may entail analysis of a series of user enteredresponses. At 175, the input data includes information concerning therecent dietary intake of the user. Data may include caloric content,nutritional content (sodium levels), quantity and type of foods. At 180,the input data may include user provided data concerning voidingpatterns or behavior. At 190, the input data may include drug intake ormedicine compliance information. At 195, the input data may includealcohol consumption information such as quantity, type and time ofintake. At 200, the input data may include transient illness informationconcerning such matters as time of onset, symptoms, treatment andrecovery. At 205, the input data may include miscellaneous predictiveinput information. For example, the user may enter data to indicate thathe will soon be walking or running or otherwise exercising. Other inputdata may also be provided depending upon the circumstances of thepatient. The user input information may be tailored by the treatingphysician using programmer 45 and portable device 35. For example, thedata collection protocol may be tailored to reduce battery consumptionby prompting the user for a response at a reduced frequency.

FIG. 12 illustrates, in block diagram form, a selection of external, ornon-invasive, devices 210 that may be implemented in one embodiment ofthe present system. It will be appreciated that more or less than theillustrated devices may be implemented in an embodiment. Externaldevices 210 provide environmental data that may be received by portabledevice 35 of the present system. Data may be generated by externaldevices 210 and provided, in digital form, to portable device 35 by awired or wireless link. FIG. 2 illustrates an embodiment of the presentsystem having environmental data source 55 including external devicedata sources.

At 215, the external device includes a blood pressure monitor. Encodedblood pressure information for the patient is provided as a function oftime or other measured parameter. At 220, the external device includesan objective measure of the patient's quality of life. In oneembodiment, this may entail a sensor adapted to correlate with qualityof life. At 225, the external device includes a temperature monitor.Encoded temperature information is provided as a function of time orother measured parameter. The measured temperature may correspond to abody temperature, an ambient temperature, or other temperature. At 230,an external device provides data concerning the sleep time of thepatient. The device may include a monitor coupled to a clock or amonitor coupled to another device corresponding to sleep time and sleepphase variation.

FIG. 13 illustrates, in block diagram form, a selection of implantabledevices 235 that may be implemented in one embodiment of the presentsystem. It will be appreciated that more or less than the illustrateddevices may be implemented in an embodiment. Implantable devices 235provide internal data that may be received by portable device 35 of thepresent system. Such data may be generated and provided, in digitalform, to portable device 35 by a wired or wireless link. The implantabledevices each provide a signal that is encoded and wirelesslycommunicated to portable device 35. FIG. 2 illustrates an embodiment ofthe present system having environmental data source 55 includingimplantable devices providing data.

At 240, the implantable device includes a heart rhythm monitor. At 245,the implantable device includes a respiration monitor. At 250, theimplantable device includes an activity monitor. At 255, the implantabledevice includes a contractility measurement device.

FIG. 14 illustrates a method for analysis of trends using one embodimentof the present system. In one embodiment, method 260 is implemented bysoftware or hardware using portable device 35 or other elements ofsystem 10. At 265, data is acquired from various sources. Referring toFIG. 2, data may be acquired from IMD 25, programmer 45, network 50,environmental data source 55 and user data source 65. At 270, theacquired data is processed according to a procedure implemented insoftware. The procedure entails analysis of the data as a function oftime or other measured parameter. At 275, the results of the dataanalysis are used to select an updated program or specify updatedoperational parameters for IMD 25. At 280, the updated program oroperational parameters are transferred and implemented by IMD 25.

In one embodiment, a security protocol is implemented. The securityprotocol may assure authorized access for communications betweenprogrammer 45 and the portable device 35. In addition, one embodimentprovides secure communications between portable device 35 and IMD 25.Authorization may be limited to reading data or reading and editingdata. Security may entail a password and username system, encryption, orother biometric authentication system to prevent unauthorized access.

The present system provides data that may be useful in trend analysis,and thus, improve health care for a patient. For example, the presentsystem may allow monitoring of device performance over an extendedduration. Long term device performance data may facilitate improvedtherapy. In addition, the present system may allow cost-effectivecompilation of patient medical data. Such historical data may provebeneficial in developing treatment protocols for the patient.

Although the invention has been described in conjunction with theforegoing specific embodiments, many alternatives, variations, andmodifications will be apparent to those of ordinary skill in the art.Other such alternatives, variations, and modifications are intended tofall within the scope of the following appended claims.

We claim:
 1. A system, comprising: an implantable medical device (MD)configured for implantation in a patient; an implantable wirelesstransmitter coupled to the IMD; a wireless receiver configured tocommunicate with the implantable wireless transmitter; a portableelectronic device (FED) coupled to the wireless receiver, the PEDconfigured to receive and store data from the IMD and to receive andstore a user input including contextual information indicative ofoperational performance of the IMD; and at least one remote deviceconfigured to communicate through a network with the PED, wherein thePED and the at least one remote device are configured for use inmonitoring patient wellness, monitoring IMD condition and IMDperformance, correlating data generated from the user input and thereceived data from the IMD to form correlated data, and dynamicallytailoring the IMD performance using the correlated data.
 2. The systemof claim 1, wherein the wireless receiver is incorporated within the PEDor is a removable separate module coupled to the PED.
 3. The system ofclaim 1, wherein the PED includes: a display configured to present aquery to the user; and a user input device configured to enable the userto enter a response or to compile contextual information, wherein thePED is configured to execute a set of instructions to present the queryand receive the response or the compiled contextual information.
 4. Thesystem of claim 1, further comprising a sensor external to the IMD, theexternal sensor including at least one of a physiological sensorassociated with the user and an environmental sensor, wherein theexternal sensor is configured to acquire external sensor data andcommunicate the external sensor data with the PED.
 5. The system ofclaim 1, wherein the PED, or the at least one remote device, or both theat least one remote device and the PED include: a data processor circuitconfigured to analyze the user input and the received data from the IMDand to generate the correlated data using the user input and thereceived data from the IMD; and a memory circuit to store the correlateddata.
 6. The system of claim 5, further comprising a sensor external tothe external sensor including at least one of a physiological sensorassociated with the user and configured to sense a physiologic parameterof the user, and an environmental sensor configured to generate ambientenvironmental data, wherein the external sensor is configured to acquireexternal sensor data and communicate the external sensor data with thePED, wherein the data processor circuit is further configured togenerate the correlated data using the external sensor data.
 7. Thesystem of claim 1, wherein the at least one remote device includes aremote programmer.
 8. The system of claim 1, further comprising a set ofinstructions for execution by the PED, wherein the PED, by executing theset of instructions, is configured to: store the received data from theIMD and the contextual data from the PED; correlate the received datafrom the IMD and the contextual data and form the correlated data; andcommunicate data to at least one of the IMD and the at least one remotedevice.
 9. The system of claim 8, wherein the PED is configured towirelessly communicate data through a wireless communication link. 10.The system of claim 9, wherein the PED is configured to updateprogramming of the IMD.
 11. A method, comprising: receiving data from animplantable medical device (IMD) implanted within a patient and datafrom at least one sensor external to the IMD; receiving a user input toa portable electronic device (PED), the user input including contextualinformation indicative of operational performance of the IMD;performing, using a data processor, data analysis and correlating thereceived data from the IMD and the received user input to formcorrelated data; communicating the correlated data with the IMD, or withat least one remote device, or with both the IMD and the at least oneremote device; and monitoring a patient wellness using the PED or the atleast one remote device; and dynamically tailoring programming of theIMD using the correlated data.
 12. The method of claim 11, wherein thedata from the IMD includes: data indicative of condition and performanceof the IMD; and one or more physiological signals indicative of patienthealth and wellness, wherein receiving the data from the IMD includesusing the PED to retrieve the data from the IMD via a wirelesscommunication link.
 13. The method of claim 11, wherein receiving theuser input to the PED includes: executing, using a processor within thePED, a set of instructions to present a query; and receiving a responseto the query.
 14. The method of claim 11, wherein receiving the externalsensor data includes: using external sensors to acquire data indicativeof a physiological condition or an environmental condition; andcommunicating the external sensor data with the PED.
 15. The method ofclaim 11, wherein correlating the received data includes correlating thedata at least from the IMD, the user input, or the external sensors,wherein the data processor resides in the PED or the at least one remotedevice.
 16. The method of claim 11, wherein performing data analysisincludes generating a data trend indicative of a medical condition. 17.The method of claim 11, wherein performing data analysis includesmonitoring IMD condition and IMD performance.
 18. The method of claim11, wherein communicating the correlated data includes wirelesscommunication.
 19. The method of claim 11, wherein tailoring programmingof the IMD includes: receiving an instruction to tailor programming ofthe IMD; and communicating with the IMD to update the programming of theIMD.
 20. The method of claim 11, wherein the data from at east onesensor external to the IMD includes temperature data or atmosphericpressure data.